Tick Borne Disease Working Group Day 2: Strong Words, Many Lingering Questions for Lyme Patients

In sum, Monday was largely ceremonial. It began with the non-federal employee members of the Working Group taking the stage to take an oath of office generally reserved for federal employees, including the President of the United States, members of U.S. Congress and the military; all members of the working group placed their hands on Bibles and swore to uphold and defend the Constitution of the United States. (It might have been reassuring for some in the patient community if the members had also had to pledge under oath to protect and defend both the public health and personal rights to wellness, given that this Working Group was developed in great part to resolve conflicts that at least half the members feel are contributing to the ongoing and otherwise treatable illnesses of many American people.)

Members then took their seats for introductions, followed by two expert presentations. First up was Greg Skall, an attorney representing the National Capital Area Lyme Disease Association—colloquially known as NatCapLyme—who detailed how ineffective policies and selective enforcement of medical guidelines harm tickborne disease patients. After Skall, LymeDisease.org’s Lorraine Johnson presented on her organization’s effort to fill in gaps created by a lack of federal or private medical investigation into Lyme disease patients’ experiences, in an effort to determine through patients’ self-reporting what is otherwise falling through the cracks.

While the first day was short, from 12:30 until 4:00, it offered two expert panels and opportunities for members of the public who had pre-identified to speak their minds for up to three minutes each.

My overview of the first day, focusing on public comments, is available here.

Day two—yesterday, Tuesday, December 13—was nearly a full day, beginning at 9:00 a.m and ending at 4:00 p.m. It opened with more expert presentations, followed by more public comments, followed by further overviews about rules of procedure and expected outcomes, followed finally by afternoon deliberations of the working group.

This researcher says that persisting forms of Lyme disease-causing bacteria Borrelia burgdorferi have been proven in human and other animal models—that case is closed and it’s time to stop debating... 1/2 https://t.co/ZfwdAIl3R9

...meanwhile, Paul Auwaerter of the IDSA thus far has not addressed persister forms but emphasizes importance not of treating patients who live with late-stage, chronic Lyme, but of developing and issuing a Lyme vaccine... 2/2 pic.twitter.com/FKnBiUQSja

Importantly, Working Group Vice Chair Kristen Honey asserted multiple times on days one and two that patient voices not only would be heard by the working group, but that for the sake of this working group, patient voices and patient experiences will be factored in with equal weight to any expert contributions.

As context, a major complaint of patients who are ultimately diagnosed with Lyme disease is that many doctors and other officials and authorities initially express great concerns about patients’ symptoms when they suspect, for example, that the patient may have developed multiple sclerosis, Parkinson’s disease, Alzheimer’s, rheumatoid arthritis or another disease for which Lyme is frequently misdiagnosed. After testing and ruling out all such diseases, patients are disturbed to discover that, failing to be able to determine what is wrong with their patients, many doctors conclude that nothing is wrong with their patients—at least physiologically. In far too many cases, patients are rejected by doctors who suggest that the patients are either pretending to be ill, or that their symptoms are simply manifestations of anxiety, depression, or another mental illness. (This was the conclusion of the first neurologist I saw, who suspected multiple sclerosis and then told me after MRIs and EMGs came back normal that “I’d be surprised if all your problems didn’t go away after a nice, long beach vacation...if not, find yourself a good therapist.”)

Avril Lavigne on Good Morning America in 2015: “I was seeing every specialist and, like, literally the top doctors. And they were just, like...it’s so stupid, they would pull up their computers and say, chronic fatigue syndrome. ‘Just try to play the piano,’ and it’s just, like, ‘Are you depressed?’ This is what they do to a lot of people that have Lyme disease. They don’t have an answer for them, so they tell them...they tell them, ‘You’re crazy.’”

So it’s heartening as a patient to hear the vice chair of the Working Group repeatedly emphasize that patient experiences—which are in general terms symptomatically consistent in most cases—will not be rejected because doctors, researchers and federal policymakers prefer to work from diagnostic laboratory data.

As the Working Group began its work—first, to develop a broad vision statement—Honey’s initial offering was “A national free of tick-borne disease where evidence-based outcomes return everyone to full wellness.” Immediately after the words were uttered, she suggested that “patient-focused” be added after “evidence-based,” and then later insisted that “patient-focused” be moved to come before “evidence-based” to emphasize the prioritization of patients. (The vision statement continued to be refined for some time—for those who have never had the arduous luxury of watching an advisory or governing body wordsmith, this was a grand opportunity to see how sausage is made in Washington and in board rooms throughout the country.)

One Criticism So Far

So far, the proceedings of the Working Group have been encouraging. At the same time, they have been largely demonstrative and foundation building rather than action oriented.

My one criticism thus far has to do with the design of the first couple of days. The Working Group was introduced as an opportunity to hash out many of the great debates and disagreements that surround Lyme disease—to get all parties on all sides together and to facilitate reasonable discussion based on all available evidence, including patient experiences.

Yesterday, two back-to-back presentations were a bit perplexing when taken together. In the first, a researcher essentially stated that Borrelia burgdorferi, the bacterium primarily associated with Lyme disease, has been proven in laboratory settings, in both human and non-human animals, to be able to persist in some circumstances through and following antibiotic treatment. Of all Lyme disease controversies, this is the polka-dotted, neon magenta elephant in the room. The next presenter, an official from the Infectious Diseases Society of America, spokes exclusively about the need to develop improved diagnostic tests and an effective vaccine for Lyme disease. He didn’t address persistence. This was a glaring omission, particularly from the IDSA, which denies that any legitimate evidence of potential persisting infection exists in human beings. By stacking these presentations—the first of which unequivocally stated something as undeniable fact, and the second of which ignored that statement while representing an organization that ignores the body of research on which the expert’s claim was made—the need to debate this of all issues within the Working Group was emphasized. And yet, there was no debate, no room and no time for debate.

I hope that that will change. If it doesn’t, then the Working Group is an entirely futile effort.

I realize that only days one and two of the Working Group have been convened so far, and it is too early to levy strong criticism—and so I am simply raising a red flag, or perhaps raising my hand as someone who has lived with Lyme probably since at least 1997, and as someone who has dedicated much of my life over the past three years to asking questions about Lyme and reading research. I’m raising my hand to ask, “Where’s the debate? When will that occur? And when it does, will these questions be asked—and conversations continued until satisfactory, thorough, and transparent answers are given?”

Questions that Should be Asked and Answered

I’ve asked many people one question, including representatives of the IDSA and including the CDC, which can only be asked at the organizational level, and which to date only answers in the vaguest and most general of terms, without nuance and often without acknowledging certain questions. That question is, Why do some scientists state conclusively that evidence of persisting Borrelia burgdorferi bacterial strains have been documented both in vitro and in vivo, including in human beings, and other scientists including officials who represent the IDSA and the CDC say that “no good evidence of persisting infection exists”? This question is at the heart of everything—the scientific debate, the persecution of medical doctors who treat chronic Lyme patients, and the inhumane attacks on Lyme disease patients themselves whose bodies stubbornly do not revert to wellness because they are told that the national infectious disease society and the federal agencies that defer to them say that ongoing infection is impossible, and ongoing, even deteriorating health problems are unlikely, or likely due to mental illness. (This opinion has made its way to mainstream news coverage through health editors, including one from the Washington Post who, while serving as Slate’s health editor, posthumously un-diagnosed a woman’s Lyme disease and replaced that diagnosis with one of clinical depression, blamed the dead woman’s doctor for her death, and then suggested that chronic Lyme disease really is nothing more than “likely depression—which is treatable.” In other words, this opinion, and the stubborn refusal of officials to debate and further research the very nature of Lyme disease, has resulted in cruel mischaractertization of people with severe, debilitating illnesses that now occurs among all media types, including reality television, which now has convinced a major part of the population that Lyme disease is a “fake” illness. On top of that, this award-winning health editor framed Lyme disease in such a way as to make it appear as if it’s a manipulative talking point of the Republican party—which I have to say as a super-liberal gay man who has lived with this disease for decades...well, I can’t put the words that conjures into writing, not here. All of this mischaracterization is unconscionable. This Working Group must resolve this debate of stubborn silence.)

The Working Group yesterday developed subgroups, each of which will address a different specific aspect of Lyme disease. Both prevention and treatment were covered. The most-discussed aspect of yesterday’s deliberations involved whether Lyme vaccine development belongs with the prevention subgroup, its own subgroup, or whether it’s beyond the scope of the Working Group altogether. One member, a patient advocate, noted that she is not an anti-vaccine activist and that, in fact, she and her daughter just got up to date on all their vaccines. Here’s why she said that: Certain parties involved in the Lyme disease debate have falsely associated people with Lyme disease with the so-called anti-vaxxer movement. That is a red herring, but because the anti-vaccine movement is so polarizing, falsely suggesting that people who have Lyme disease and our advocates are somehow affiliated with people who reject all vaccines is a way to immediately turn tribally minded people against us; it’s no different than the health editor mentioned in the above point, who falsely suggested that people with Lyme are either so naive or so dumb as to be wooed to vote for a political candidate because he dared to acknowledge that people who suffer with Lyme disease have Lyme disease. It’s a shame that a member of the Working Group had to assert that she’s not an anti-vaxxer when suggesting that vaccines discussions may be so intensive as to be beyond the scope of the prevention subgroup. When vaccines are discussed, here is an important question that should be asked both for the sake of full transparency and to resolve questions that to date have been ignored: Do any parties who prioritize the development of vaccines and diagnostics stand to profit personally from the development of these products? This question is vitally important because a number of officials at the IDSA who prioritize vaccines and often do not even address the suffering of existing Lyme disease patients disclose in academic papers that they hold shares in major healthcare companies—including those that develop and market vaccines and diagnostic tests for profit—and should a vaccine be developed and become federally mandated, then those individuals’ judgment potentially may be compromised by an eventual financial payoff from profits of such products becoming mandated by federal policy or federal recommendation, or by local school boards. None of this suggests that a vaccine would do harm, or serves as any judgment of the efficacy of a potential vaccine; rather, it asks questions about the motivation for an exclusive focus on advocating on behalf of a vaccine while ignoring the ongoing extraordinary suffering of countless Lyme disease patients.

The Lyme disease patient community has been extremely critical of the CDC, whose mission is disease control and disease prevention. Spraying for ticks, development of a vaccine, and so on fall under the control and prevention mandate of the CDC. Criticisms of the CDC have stemmed from the CDC’s historic endorsement of the IDSA Lyme disease guidelines developed in 2006. On December 1, the CDC removed links and explicit references to the IDSA Lyme guidelines from its website, explaining to me via email that it did so because it determined the guidelines to be outdated. The CDC made this decision to remove links to the guidelines nearly two years after another HHS agency, which operates the National Guidelines Clearinghouse, removed the IDSA guidelines for the same reason. It should be noted, too, that federal regulations require that guidelines be reviewed against current evidence at least every five years—and so they were supported by the NGC for a full five years after their expiration date and nearly seven years after their expiration date by the CDC. As someone whose job involves asking questions, I’ve been frustrated by CDC’s responses—I’m glad they respond, but the responses are so political as to rarely answer the actual questions I asked. Why would the CDC continue to endorse guidelines for almost seven years after they are determined by federal regulation to be no longer fit for public use? And why, when the NGC accepted guidelines from the International Lyme and Associated Diseases Society (ILADS) two years ago, does the CDC not even acknowledge the existence of those guidelines to this day, instead removing the IDSA guidelines but recommending a literature review co-authored by some of the IDSA co-authors that ultimately supports and refers readers to the IDSA Lyme disease guidelines? Without transparency and a sound explanation, all of this conveys an almost irrefutable appearance of the CDC—a federal public health agency—favoring one professional medical association over another. And so, if the Working Group is to make any real progress in this conversation, the working group then must make an effort to solicit and must procure fully transparent, full, sound explanations for the federal government’s decision.

At the same time, the historic focus of the Lyme community on the CDC has been a distraction from making progress on research. It’s understandable how this happened: The CDC’s apparent bias toward IDSA guidelines, which prohibit treatment with antibiotics for longer than 28 days (for Lyme—this is not the case for a variety of other diseases), has had the effect of influencing medical boards to persecute medical doctors who treat Lyme patients, often with great success, for longer than 28 days, whereas patients fail without this treatment. Here’s how that works: When the CDC recommends medical practice guidelines, medical boards often interpret the CDC’s recommendations as a kind of regulation, or law. In reality—and this was even pointed out to me by a representative of the CDC recently—medical guidelines are guides, not laws, even when endorsed by a federal agency. In many cases, doctors follow guidelines rather loosely, using them as a...well, as a guide, but practicing the art of medicine, and looking to the patient’s self-reported health and to labs to determine whether treatment is succeeding or failing. In the case of Lyme disease, the guidelines somehow have been interpreted as absolute law and followed rigidly. Lyme disease specialists have told me over the years that they have been “harassed” by the CDC when they stray from the guidelines, and that they are either threatened with investigation or investigated by medical boards, which are told by the CDC (or by medical insurers) that board-certified doctors are straying from the federally supported guidelines and therefore may be malpracticing and harming patients. Lyme specialists know that they are at a relatively high risk of having their licenses to practice suspended or revoked as a result. And so here we have a complication that needs to be resolved. Since a CDC employee posed the question to me, I will redirect the question to the Working Group: Why are CDC-endorsed practice recommendations for Lyme disease used to persecute medical doctors who stray from them when this supposedly is not common in the practice of other diseases? Addressing this may involve looking beyond the CDC at medical boards themselves, and assessing what experiences they have with allegedly being encouraged by the CDC and by health insurers to investigate and punish medical doctors who treat Lyme disease patients according to ILADS guidelines instead of IDSA guidelines.

And finally, beyond the CDC, perhaps my greatest frustration is why seemingly no one looks to the NIH when identifying the federal government’s effects on the Lyme epidemic. The National Institutes of Health funds and mandates medical research—CDC does not do that. Since Lyme disease is so prevalent—actually one of the most prevalent infectious diseases in the country—and since patients report such extraordinarily dire effects from untreated or improperly treated Lyme, resulting in a high suicide rate among Lyme patients who can no longer life with their suffering, the paltry $25 million NIH investment in Lyme disease research is truly baffling. By comparison, NIH for years has invested an average of $3 billion in HIV research, with fewer than 40,000 new HIV infections occurring per year, compared with over 300,000 Lyme disease infections. Why has the NIH been so lax in allocating funds to research Lyme disease? What has influenced NIH officials to ignore the pleas for help by so many national, regional and local advocacy groups? How can the Working Group influence an adequate and equitable investment in research for Lyme and other tickborne diseases—an investment of at least a billion dollars. (For comparison’s sake, President Obama in 2016 requested $1.8 billion in emergency funding for the Zika virus because of its potential to become an epidemic, and Congress awarded $1 billion in funds. Lyme disease has been an epidemic for years, but NIH still funds it at the level of a “rare disease.”)

Just some thoughts.

I am encouraged by the spirit presented by the Tick Born Disease Working Group. I’m less convinced at this point of its potential for making real change—but I’m less convinced because so far the groundwork has only begun to be laid down.

I will be watching and listening for actual debate to take place, for ironing out rather than talking around the crucial questions that continue to make Lyme disease such a bizarrely marginalized and ignored illness even as infection rates and tick habitats aggressively broaden.

And then I’ll be looking for some of these issues to be settled, or at least for conclusions to be drawn, followed by sound, actionable recommendation to be made by the Working Group to the federal government. And then whether the federal government is obligated to or interested in heeding the recommendations of an advisory board with no governing power is another question altogether, likely to be vulnerable to influences behind closed doors, such as the interests of lobbyists from pharmaceutical and healthcare companies, national medical associations, and others.

Oprah Winfery made a saying by Maya Angelou famous. That saying, according to Winfrey, is “When you know better, you do better.”

That sounds great. It doesn’t appear to be what Angelou actually said, however. This is:

“When you know better, you do better” is an affirmation that assumes people act according to basic decency. The past year’s politics—broadly speaking, not specifically relating to Lyme—really haven’t illustrated that.

Maya Angelou was brilliant, and she was not so naive as to assert that people automatically do better once they have certain information.

I think it’s important to realize now that Angelou’s words are a challenge against temptation not to do the decent thing once we realize that what we’ve been doing has been causing harm.

I really, really hope that not only the members of the Working Group, but those in the government who receive their report, will live up to the challenge.